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  • April 30 2022 Aileen Ryan

    The Investigator Responsibilities in IND Safety Reporting

    An important aspect of PROMETRIKA’s work as a full-service CRO for sponsors is the monitoring and reporting of safety-related events during clinical trials. Our sponsor colleagues focus on drugs and biologics addressing rare diseases and other conditions that so far have proven difficult to treat. PROMETRIKA’s Safety and Pharmacovigilance activities are focused on accurate and timely drug safety reporting.

    • Drug Safety
    • Full-service CRO
    • Pharmacovigilance
    • IND
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  • March 31 2022 Aileen Ryan

    The Sponsor’s Responsibilities in IND Safety Reporting

    An important aspect of PROMETRIKA’s work as a full-service CRO for sponsors is the monitoring and reporting of safety-related events during clinical trials. Our sponsor colleagues focus on drugs and biologics addressing rare diseases and other conditions that so far have proven difficult to treat. PROMETRIKA’s Safety and Pharmacovigilance activities are focused on accurate and timely drug safety reporting.

    • Drug Safety
    • Full-service CRO
    • Pharmacovigilance
    • IND
    • SAE
    Continue Reading
  • February 28 2022 Barry Mirrer

    Checklists Can be a Piece of Cake

    Checklists. Some people hate them; some people love them. There have been whole books written about them. Some checklist fans say they live by their checklists. Cynics may see checklists as long, tedious, ineffective, bothersome, or just plain wrong. And, well, that’s sometimes true.

    So what makes a good and effective checklist?

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  • January 31 2022 Susan Mutter

    CDISC SDTM Certification

    I can actually say that I have been working in the Clinical Trials industry since the last century.  I started as a database programmer, part of data management in a large (now huge) CRO.  In those days we used paper CRFs, entered by hand into a database platform that was built and maintained inhouse.  We had our own naming conventions for variables and could pretty much build whatever we wanted and group the data however it made sense to us.  Prior to deliverables, we printed out the entire database so data managers could review it. All the files were burned to floppy discs and we’d pop them in the mail to the sponsor.  With the amount of data we collect, and the requirement to do more, faster, can you even imagine doing that now?

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  • December 23 2021 Suzanne Granger

    Adaptive Design Options for Dose Finding Trials

    The objective of phase 1 dose-finding studies is to determine the maximum tolerated dose (MTD), defined as the highest dose at which a pre-specified proportion of subjects experience a dose limiting toxicity (DLT). Ideally, the trial design would not only be easy to implement but also efficient and ethical. In recent years, several statistical models for adaptive trial designs have emerged.

    • Maximum tolerated dose
    • MTD
    • Bayesian
    • BOIN
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Recent Posts

  • Decentralized Clinical Trials, Part 2 - The Current Landscape
  • Decentralized Clinical Trials, Part 1 – Its History (and Future?)
  • Certification for European Regulations: More Than "Familiar"…
  • Adjustment of Covariates in Randomized Trials
  • Estimands Framework in Clinical Trials: Choosing the Best Strategy
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